MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TRAP,MUCUS, 10FR, DELEE, W/VALVE

Catalog Number	DYND44110
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2026, "during delivery, an infant was being suctioned, and the team could not get an appropriate suction when the delee was attached." the customer reported the " infant was stabilized and the team went to further test the equipment." when suction tubing alone was attached, the suction pressure was appropriate.However, when the delee device was attached, the suction pressure decreased and required the wall suction to be increased significantly to function.Clinical staff reported that compared to previous batches, the current product requires higher suction settings than they are accustomed to using.The customer reported no injury occurred, and no follow up medical, surgical, or additional treatment was required.
Event or Problem Description
According to the customer, on (b)(6) 2026, "during delivery, an infant was being suctioned, and the team could not get an appropriate suction when the delee was attached.".

• Brand Name: MEDLINE
• Common Device Name: TRAP,MUCUS, 10FR, DELEE, W/VALVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sara young ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24848043
• Report Number: 1417592-2026-00413
• Device Sequence Number: 20249942
• Product Code: BYZ
• UDI-Device Identifier: 10080196997404
• UDI-Public: 10080196997404
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYND44110
• Device Lot Number: 18325100001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown